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ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company, focused on developing novel medicines for diabetic eye disease, announces the enrollment of the first patients in a Phase II, single-masked, multicenter exploratory study evaluating the safety and efficacy of 2 dose levels of THR-317 for the treatment of diabetic macular edema (DME).
THR-317 (anti-PIGF) is a recombinant human monoclonal antibody directed against the receptor-binding site of human placental growth factor (PlGF).
The Phase II study will evaluate the safety of 3 intravitreal injections of 2 dose levels of THR-317 (4 mg or 8 mg). The trial will also assess THR-317's ability to improve best-corrected visual acuity (BCVA) and to reduce central retinal thickness in subjects with DME.
Recent preclinical data evaluating THR-317 (using a research grade anti-PlGF antibody) have confirmed a number of potential advantages of an anti-PlGF antibody for the treatment of DR when compared to the current standard of care. Therefore, ThromboGenics believes that THR-317 could be used as a stand-alone therapy or as an add-on treatment to anti-VEGF medicines, for the treatment of DME or DR
The study plans to enroll a total of 50 patients over a period of about 12 months. The first results from the study are expected in Q1 2018.
Dr Patrik De Haes, CEO of ThromboGenics nv, said, "Knowing that 35% of all diabetes patients will in their lives develop some form of diabetic retinopathy (DR), there is a clear unmet medical need and an increasing demand for improved or add-on treatment options. We believe that our anti-PlGF antibody THR-317 holds the potential to differentiate and improve current standard of care for this important sight-threatening disease. We are very pleased to see the first patients being recruited."
Dr András Seres, Ophthalmologist and Director at/of Budapest Retina Associates comments, "The pre-clinical data I have seen highlight this anti-PlGF antibody's potential advantages over the current standard of care in DR. With clinicians and patients in need of additional safe and effective therapies for the treatment of DR, these data provide strong rationale for taking the compound into the clinic."
ThromboGenics plans on evaluating THR-317 in additional DR indications if the current Phase II trial delivers positive results.
ThromboGenics is a biopharmaceutical company focused on developing innovative treatments for diabetic eye disease. The company's pipeline of disease modifying drug candidates is targeting the key segments of the diabetic eye disease market.
ThromboGenics is conducting the CIRCLE study, a Phase II clinical trial evaluating multiple doses of THR-409 (ocriplasmin) to induce a total Posterior Vitreous Detachment in patients with Non-Proliferative Diabetic Retinopathy (NPDR).
Early 2017, ThromboGenics enrolled its first patient in a Phase II clinical study evaluating THR-317, a PIGF inhibitor for the treatment of diabetic macular edema, as a stand-alone or as a combination therapy with anti-VEGF treatments.
In addition, THR-149, a plasma kallikrein inhibitor, which has resulted from research collaboration with Bicycle Therapeutics, and THR-687, an integrin antagonist, which was in-licensed from Galapagos, are in late stage pre-clinical development.
ThromboGenics pioneered a new drug category of pharmacological vitreolysis with JETREA® (ocriplasmin) which is now approved for the treatment of vitreomacular traction in 54 countries worldwide. ThromboGenics is commercializing JETREA® via its subsidiary ThromboGenics, Inc. in the US. Novartis commercializes JETREA® outside the United States.
ThromboGenics is headquartered in Leuven, Belgium, and is listed on the NYSE Euronext Brussels exchange under the symbol THR.